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Safety and Efficacy Study of ONGLYZA (Saxagliptin) Under Conditions of Actual Use (ONGLYZA PMS)

This study has been terminated.
(Inability to recruit adequate number of patients within the specified time period.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01223456
First Posted: October 19, 2010
Last Update Posted: October 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
This post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2 and are prescribed ONGLYZA by their physician.

Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Descriptive Study of the Efficacy and Safety of ONGLYZA (Saxagliptin) Under Conditions of Actual Use in the Philippines

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse events observed during the treatment duration [ Time Frame: Upon enrollment and initiation of Saxagliptin up to 14 days post follow-up ]
  • Clinical Response determined by cure rate [ Time Frame: Up to three (3) months after initiation of treatment ]

Enrollment: 542
Study Start Date: October 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
several private and government hospitals
Criteria

Inclusion Criteria:

  • Diagnosis of Type 2 Diabetes Mellitus
  • Prescribed Saxagliptin by patient's attending physician

Exclusion Criteria:

  • Known allergic or serious adverse reaction to Saxagliptin
  • Pregnant or breastfeeding patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223456


Locations
Philippines
Research Site
Batangas City, Batangas, Philippines
Research Site
Cebu City, Cebu, Philippines
Research Site
Davao City, Davao, Philippines
Research Site
Iloilo City, Iloilo, Philippines
Research Site
Las Pinas City, Manila, Philippines
Research Site
Makati, Manila, Philippines
Research Site
Pasig, Manila, Philippines
Research Site
Quezon City, Manila, Philippines
Research Site
Mabalacat, Pampanga, Philippines
Research Site
Manila, Philippines
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Milagros Tan, MD AstraZeneca Philippines
Study Chair: Emmanuel Arca, MD AstraZeneca Philippines
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01223456     History of Changes
Other Study ID Numbers: NIS-CPH-DUM-2010/1
First Submitted: October 14, 2010
First Posted: October 19, 2010
Last Update Posted: October 8, 2013
Last Verified: October 2013

Keywords provided by AstraZeneca:
Saxagliptin
type 2 diabetes
clinical practice

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents